Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004902-85 | EudraCT Number |
Not provided
Not provided
Not provided
Study stopped due to a safety signal of drug-induced liver injury in subjects receiving 2158
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABI-H2158 plus ETV | Experimental | ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks |
|
| Placebo plus ETV | Placebo Comparator | Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-H2158 | Drug | 3 X 100 mg tablets for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | Describes the number of participants with One or More Adverse Events while they were on treatment with the study drug. | Up to 72 weeks |
| Percentage of Participants With Premature Treatment Discontinuation | Describes the number of participants who discontinued treatment with ABI-H2158/placebo prematurely. | Up to 72 weeks |
| Change From Baseline in Mean log10 HBV DNA | HBV DNA was measured by Cobas AmpliPrep/ Cobas TaqMan HBV Test v2.0 (LOD 10 IU/mL). The analysis of data was descriptive only. | Baseline and Week 24 |
| Percentage of Participants With Abnormal Laboratory Results | Severity grades were defined by Grading Scale for Severity of Adverse Events and Laboratory Abnormalities [The DAIDS Version 2.1]. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. For each individual laboratory test, the most severe graded abnormality for that test was counted for a participant. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last dose of ABI-H2158/Placebo plus 28 days. | Up to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Plasma Concentration of ABI-H2158 | Predose on Day 1, Week 4, Week 48, and Week 72 | |
| Trough-to-Peak Plasma Concentration Ratio of ABI-H2158 | Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Grace Wang | Assembly Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coalition of Inclusive Medicine | Los Angeles | California | 90020 | United States | ||
| California Liver Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ABI-H2158 Plus ETV (HBeAg Positive Population) | ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks ABI-H2158: 3 X 100 mg tablets for oral administration Entecavir (ETV): 0.5 mg tablet for oral administration |
| FG001 | Placebo Plus ETV (HBeAg Positive Population) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Sugar pill manufactured to mimic the ABI-H2158 tablets |
|
| Entecavir (ETV) | Drug | 0.5 mg tablet for oral administration |
|
| Trough Plasma Concentration of ETV | Predose on Day 1, Week 4, Week 48, and Week 72 |
| Trough-to-Peak Plasma Concentration Ratio of ETV | Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28 |
| Change in Mean log10 HBV pgRNA From Baseline to Week 24 and at Each Timepoint for ABI-H2158+ETV and PBO+ETV | up to Week 72 |
| Number of Participants With Reduction in HBV DNA Below the Assay Lower Limit of Quantitation | Up to 72 weeks |
| Number of Participants With Reduction in HBV pgRNA Below the Assay Lower Limit of Quantitation | Up to 72 weeks |
| Change From Baseline in Serum HBV Surface Antigen (HBsAg) | Baseline and up to 72 weeks |
| Change From Baseline in Serum HBV "e" Antigen (HBeAg) | Baseline and up to 72 weeks |
| Change From Baseline in Serum HBV Core-related Antigen (HBcrAg) | Baseline and up to 72 weeks |
| Proportion of Subjects With Abnormal ALT at Baseline Who Have Normal ALT at Week 24 and at Each Timepoint on ABI-H2158+ETV and PBO+ETV | Baseline and up to Week 24 |
| Ncidence of HBV Variants With Reduced Susceptibility to ABI-H2158 | Up to 72 weeks |
| Change in Mean log10 HBV DNA for ABI-H2158+ETV and PBO+ETV at Each Timepoint | up to 72 weeks |
| Pasadena |
| California |
| 91105 |
| United States |
| Stanford University Medical Center | Redwood City | California | 94063 | United States |
| Research and Education Inc. | San Diego | California | 92105 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| University of Miami/Schiff Center for Liver Diseases | Miami | Florida | 33136 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| New Discovery, LLC | Flushing | New York | 11355 | United States |
| Northwell Health Center for Liver Disease | Manhasset | New York | 11030 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| St. Vincent's Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| John Hunter Hospital | New Lambton | New South Wales | 2305 | Australia |
| Gallipoli Medical Research Foundation | Greenslopes | Queensland | 4120 | Australia |
| St. Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Melbourne Health | Parkville | Victoria | 3050 | Australia |
| (G.I.R.I.) GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The Second Affliated Hospital of Chongqing Medical University | Chongqing | Yuzhong District | 400010 | China |
| Xiangya Hospital Central South University | Changsha | 410008 | China |
| Nanfang Hospital | Guangzhou | 510515 | China |
| Guangzhou Eighth People's Hospital - Guangzhou Infectious Diseases Hospital | Guangzhou | China |
| Prince of Wales Hospital | Shatin | New Territories | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Auckland Clinical Studies | Auckland | 2105 | New Zealand |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| Hallym University Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon-do | 24253 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 07061 | South Korea |
| Kaohsiung Medical University Hospital | Kaohsiung City | Sanmin District | 80756 | Taiwan |
| China Medical University Hospital | Taichung | 44047 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Mackay Memorial Hospital Taipei Branch | Taipei | 10449 | Taiwan |
| Chang Gung Memorial Hospital (CGMH) - Linkou Branch | Taoyuan | 333 | Taiwan |
| King's College Hospital | London | SE5 9RS | United Kingdom |
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
| FG002 | ABI-H2158 Plus ETV (HBeAg Negative Population) | ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks ABI-H2158: 3 X 100 mg tablets for oral administration Entecavir (ETV): 0.5 mg tablet for oral administration |
| FG003 | Placebo Plus ETV (HBeAg Negative Population) | Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABI-H2158 Plus ETV (HBeAg Positive Population) | ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks ABI-H2158: 3 X 100 mg tablets for oral administration Entecavir (ETV): 0.5 mg tablet for oral administration |
| BG001 | Placebo Plus ETV (HBeAg Positive Population) | Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
| BG002 | ABI-H2158 Plus ETV (HBeAg Negative Population) | ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks ABI-H2158: 3 X 100 mg tablets for oral administration Entecavir (ETV): 0.5 mg tablet for oral administration |
| BG003 | Placebo Plus ETV (HBeAg Negative Population) | Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | Describes the number of participants with One or More Adverse Events while they were on treatment with the study drug. | Posted | Count of Participants | Participants | Up to 72 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Premature Treatment Discontinuation | Describes the number of participants who discontinued treatment with ABI-H2158/placebo prematurely. | Posted | Count of Participants | Participants | Up to 72 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Mean log10 HBV DNA | HBV DNA was measured by Cobas AmpliPrep/ Cobas TaqMan HBV Test v2.0 (LOD 10 IU/mL). The analysis of data was descriptive only. | Due to early termination of the study, samples at Week 24 from participants in the HBeAg negative cohort were not collected. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Abnormal Laboratory Results | Severity grades were defined by Grading Scale for Severity of Adverse Events and Laboratory Abnormalities [The DAIDS Version 2.1]. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. For each individual laboratory test, the most severe graded abnormality for that test was counted for a participant. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last dose of ABI-H2158/Placebo plus 28 days. | Posted | Count of Participants | Participants | Up to 72 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Plasma Concentration of ABI-H2158 | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Predose on Day 1, Week 4, Week 48, and Week 72 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough-to-Peak Plasma Concentration Ratio of ABI-H2158 | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Plasma Concentration of ETV | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Predose on Day 1, Week 4, Week 48, and Week 72 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough-to-Peak Plasma Concentration Ratio of ETV | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean log10 HBV pgRNA From Baseline to Week 24 and at Each Timepoint for ABI-H2158+ETV and PBO+ETV | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | up to Week 72 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reduction in HBV DNA Below the Assay Lower Limit of Quantitation | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Up to 72 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reduction in HBV pgRNA Below the Assay Lower Limit of Quantitation | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Up to 72 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum HBV Surface Antigen (HBsAg) | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Baseline and up to 72 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum HBV "e" Antigen (HBeAg) | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Baseline and up to 72 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum HBV Core-related Antigen (HBcrAg) | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Baseline and up to 72 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Abnormal ALT at Baseline Who Have Normal ALT at Week 24 and at Each Timepoint on ABI-H2158+ETV and PBO+ETV | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Baseline and up to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Ncidence of HBV Variants With Reduced Susceptibility to ABI-H2158 | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | Up to 72 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean log10 HBV DNA for ABI-H2158+ETV and PBO+ETV at Each Timepoint | Due to early termination of the study, data were not collected and analyzed for secondary outcomes. | Posted | up to 72 weeks |
|
Up to 72 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABI-H2158 Plus ETV (HBeAg Positive Population) | ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks ABI-H2158: 3 X 100 mg tablets for oral administration Entecavir (ETV): 0.5 mg tablet for oral administration | 0 | 32 | 1 | 32 | 18 | 32 |
| EG001 | Placebo Plus ETV (HBeAg Positive Population) | Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration | 0 | 11 | 1 | 11 | 6 | 11 |
| EG002 | ABI-H2158 Plus ETV (HBeAg Negative Population) | ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks ABI-H2158: 3 X 100 mg tablets for oral administration Entecavir (ETV): 0.5 mg tablet for oral administration | 0 | 33 | 0 | 33 | 19 | 33 |
| EG003 | Placebo Plus ETV (HBeAg Negative Population) | Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration | 0 | 12 | 1 | 12 | 6 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tibia fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Altered state of consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| white blood cell count decreased | Investigations | Systematic Assessment |
| ||
| hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| vaccination complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| rash erythematous | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| folliculitis | Infections and infestations | Systematic Assessment |
| ||
| anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| depression | Psychiatric disorders | Systematic Assessment |
| ||
| Dyslipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Foot Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Haemoglobin Decreased | Investigations | Systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Hyperlactacidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| International Normalised Ratio Increased | Investigations | Systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Systematic Assessment |
| ||
| Large Intestine Polyp | Gastrointestinal disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Libido Increased | Psychiatric disorders | Systematic Assessment |
| ||
| Ligament Sprain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lymphocyte Count Decreased | Investigations | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Menstruation Delayed | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Mesenteric Panniculitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Metabolic Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Monocyte Count Increased | Investigations | Systematic Assessment |
| ||
| Muscle Twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutrophil Count Decreased | Investigations | Systematic Assessment |
| ||
| Ocular Hyperaemia | Eye disorders | Systematic Assessment |
| ||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Platelet Count Decreased | Investigations | Systematic Assessment |
| ||
| Poor Quality Sleep | Nervous system disorders | Systematic Assessment |
| ||
| Post Vaccination Syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Prothrombin Time Prolonged | Investigations | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash Pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Respiratory Alkalosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinus Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Supraventricular Extrasystoles | Cardiac disorders | Systematic Assessment |
| ||
| Thermal Burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tibia Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tooth Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Transaminases Increased | Investigations | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Viral Infection | Infections and infestations | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weight Decreased | Investigations | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Gamma-Glutamyltransferase Increased | Investigations | Systematic Assessment |
| ||
| Amylase Increased | Investigations | Systematic Assessment |
| ||
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
| ||
| Blood Creatine Phosphokinase Increased | Investigations | Systematic Assessment |
| ||
| Blood Lactate Dehydrogenase Increased | Investigations | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Altered State Of Consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
Study ABI-H2158-201 was terminated early due to alanine aminotransferase (ALT) elevations among study participants who received ABI-H2158 (and not among those who received PBO). Further details on these events are described in the results section below. In the absence of an alternative etiology for the ALT elevations, further clinical development of ABI-H2158 was terminated by the Sponsor.
Assembly Biosciences agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Assembly Biosciences supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director of Clinical Operations | Assembly Biosciences | 833-509-4583 | Clinicaltrials@assemblybio.com |
| Aug 3, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
| South Korea |
|
| Hong Kong |
|
| United States |
|
| China |
|
| Taiwan |
|
| United Kingdom |
|
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
|
|
| OG003 | Placebo Plus ETV (HBeAg Negative Population) | Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
|
|
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks ABI-H2158: 3 X 100 mg tablets for oral administration Entecavir (ETV): 0.5 mg tablet for oral administration |
| OG003 | Placebo Plus ETV (HBeAg Negative Population) | Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
|
|
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
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| Placebo Plus ETV (HBeAg Negative Population) |
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
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Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
| Placebo Plus ETV (HBeAg Negative Population) |
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
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Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
|
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
|
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
|
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
|
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
|
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
|
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
|
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV): 0.5 mg tablet for oral administration
|
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks Placebo: Sugar pill manufactured to mimic the ABI-H2158 tablets Entecavir (ETV): 0.5 mg tablet for oral administration |
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